Category: Clinical Stones: Ureteroscopy
Introduction & Objective :
Silicone was one of the first materials to be used for DJ ureteral stents. Due to its softness, it is purported to be associated with less patient discomfort. However, there are no clinical trials showing this. In this large multicenter prospective study, we compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex Plus® stent (Boston Scientific) in terms of patient comfort after flexible ureteroscopy (FURS) for stone disease over a 5-week prospective follow-up.
Between November 2013 and December 2017, 141 patients treated for unilateral renal stones from 5 to 25 mm by F-URS were randomized under a prospective, comparative, single blind, parallel groups protocol across 4 centres in France, the UK and Canada. The primary endpoint was USSQ Body Pain Index recorded before DJ removal at D20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7) and 2 weeks after stent withdrawal (D35), pain score, quality of life, adverse events, and encrustation. Exclusion criteria included pregnancy, active infection, chronic pain, urogenital tumor, presence of an implanted double J stent, treatment for BPH, prostatitis, or neuro/cognitive disease. Treatment A (silicone Imajin® hydro) and treatment B (Percuflex Plus®) were assigned using a blocked centralized randomization list.
The table below presents the intent-to-treat analysis results. No difference was noticed between the 2 groups regarding demographic characteristics, clinical history, size and treatment of stone or initial pain. D20 USSQ Body Pain Index were available for 104 patients, showing a statistically significant difference in favour of the Imajin hydro® silicone stents compared to Percuflex Plus®.
The primary results of this large sample prospective comparative randomized study comparing the Coloplast Imajin® hydro silicone stents to the Boston Scientific Percuflex Plus® stent shows that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.
Oliver Wiseman– Urologist, Cambridge University Hospitals, Urology, Cambridge, United Kingdom, CAMBRIDGE, England, United Kingdom
Julien Letendre– Montreal, Quebec, Canada
Jonathan Cloutier– Quebec, Quebec, Canada
Michel Daudon– CRISTAL Laboratory, Laboratoire des Lithiases, Service des Explorations Fonctionnelles Multidisciplinaires, INSERM, UMRS 1155 UPMC, Tenon Hospital, Paris, France, Paris, Ile-de-France, France
Francois Kleinclauss– Head urological unit, CHRU Besançon, Besançon, Franche-Comte, France
Steeve Doizi– Urologist, Sorbonne Université, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, AP-HP, Hôpital Tenon, F-75020 Paris, France, Paris, Ile-de-France, France
Olivier Traxer– Professor, Sorbonne Universite, GRC n020 Lithiase Renale, AP-HP, Hospital Tenon, F-75020 Paris, France, Paris, Ile-de-France, France
Cambridge University Hospitals, Urology, Cambridge, United Kingdom
CAMBRIDGE, England, United Kingdom
Oliver is a Consultant Urologist based at Cambridge University Teaching Hospitaks NHS Trust Cambridge, UK. He specialises in the treatment of kidney stones, their metabolic management and in the devlopment of patient reported outcomes for stone disease. He runs a number of training courses teaching stone surgery, and has been invited to operate and lecture nationally and internationally on stone disease.
He qualified in Cambridge and following basic surgical training, he underwent specialist training in urology in London, including at Guys Hospital and UCLH ("The Institute of Urology"). He has published widely including articles relating to the management of patients with renal stone disease.
He is a trustee of BAUS, honorary treasurer elect of BAUS, a member of the BAUS Section of Endourology Committee, and on the Endourological Society Awards and Medals Committee. He is training program director for Urology for the East of England.
CRISTAL Laboratory, Laboratoire des Lithiases, Service des Explorations Fonctionnelles Multidisciplinaires, INSERM, UMRS 1155 UPMC, Tenon Hospital, Paris, France
Paris, Ile-de-France, France
Sorbonne Université, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, AP-HP, Hôpital Tenon, F-75020 Paris, France
Paris, Ile-de-France, France